The Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania proposes an innovative research training program in biostatistics for pre-doctoral training in renal and urologic biostatistics, specifically designed to strengthen the links among biostatistics, clinical nephrology, clinical urology, and clinical epidemiology. The training program relies on existing collaborative relationships among biostatistics and epidemiology faculty within the CCEB, faculty within the Renal-Electrolyte Division of the University of Pennsylvania, faculty within the Division of Urology, and faculty within the Department of Statistics in the Wharton School of Business at the University of Pennsylvania. The objective of the program is to train individuals to be rigorous and independent academic investigators, able to use the range of approaches in biostatistics to address issues in kidney and urology research. This includes the application of general biostatistics methods such as the analysis of longitudinal outcomes, meta-analysis, clinical trial design, and ethical issues in clinical research. This training also includes the development and/or application of novel biostatistical methods needed to address issues specific to kidney and urology research, such as competing risks due to multiple sources of study withdrawal, evaluation of symptom outcomes subject to placebo effects and regression to the mean, and nested case-control studies using existing national databases. The four-to five-year training program for pre-doctoral students provides didactic training in fundamental skills, methodologies, and principles of biostatistics, with specific emphasis on the areas of most importance to renal and urologic research. Specific courses are offered in general and advanced biostatistics and research methodology, leading toward a Ph.D. degree in Biostatistics. Students also will be required to obtain a strong background in substantive areas related to renal and urologic diseases. Courses are supplemented by attendance at, and participation in, research seminars and journal clubs. In addition, faculty mentors will lead students through directed experiences in collaborative research and consultation. Specifically, the training program is designed to: (1) provide in-depth knowledge of the biostatistics techniques appropriate to research in kidney and urological disease; (2) provide research experience with mentors in biostatistics and renal and urologic research; and (3) bring together faculty and students through participation in seminar series in the CCEB and the respective clinical departments. Strengths of the program are the emerging training program in biostatistics offered by the CCEB; the wide ranging experience of the biostatistics faculty in multiple areas of biostatistics methods and kidney and urology research; the established teaching program in statistics offered by the Wharton School; the long history of successful research training programs in clinical epidemiology offered by the CCEB; and the collaborative links among biostatistics and epidemiology faculty within the CCEB, faculty members within the Renal-Electrolyte Division, faculty members within the Division of Urology, and statistics faculty within the Wharton School. Available resources include several existing large databases available to students that can be tapped for biostatistics training, a broad array of ongoing research projects being conducted within the CCEB (e.g., clinical trials, case-control, cohort research), Penn's commitment to collaborative research and training, and the broad range of experiences of faculty participating in this training program.